The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients

Not Applicable

Completed

• Conditions: Sleep Quality; Vital Signs

• Registration Number: NCT05970614
• Lead Sponsor: Osmaniye Korkut Ata University

Brief Summary

This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.

Detailed Description

The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-01
• Study Start: 2023-09-01
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18 years and over,
• Able to answer all questions and communicate,
• Those who agreed to participate in the research
• Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
• Not sedating
• Not connected to a ventilator
• No hearing problem
• Glasgow Coma Score of 15

Exclusion Criteria

• Connecting to the ventilator during operation
• Sedation during the study
• Wanting to leave the research during the study
• Being in the intervention group and removing the eye patch or earplug during sleep
• GCS falling below 15

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vital signs follow-up form	up to 3 days	It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
Personal questionnaire	Only one times. At the first meeting (up to one day).	It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
Insomnia Severity Index	up to 3 days	It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
Richards-Campbell Sleep Scale	up to 3 days	The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.

Trial Locations

Locations (1)

Osmaniye Public Hospital; 🇹🇷 Osmaniye, Merkez, Turkey